Clinical Profile And Outcomes Of Neonatal Convulsions In The Neonatal Intensive Care Unit At Assiut University Children's Hospital

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-30
SponsorAssiut University

About this trial

Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth, infections, metabolic disturbances, or structural abnormalities. Many seizures in newborns are subtle and difficult to detect without careful clinical assessment.

This study aims to determine how often neonatal convulsions occur among newborns admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital. It will describe how affected newborns present clinically, identify the main causes, and evaluate the early outcomes during hospitalization.

The study is designed as a prospective cohort study. Newborns aged 0-30 days who are diagnosed with neonatal convulsions will be enrolled and followed throughout their stay in the NICU. Each patient will undergo full clinical evaluation and standard laboratory and imaging investigations, including blood tests, neuroimaging, and other tests as clinically indicated.

The findings of this study will provide updated local data on the incidence, causes, and outcomes of neonatal convulsions in our region. This information may help improve early diagnosis, guide appropriate treatment, and enhance the quality of neonatal care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged between 0 to 30day.

Children diagnosed with neonatal seizures

All newborn fullterm,preterm.males and females with neonatal convulsions.

Disqualifiers

Children above age of 30 day and those with mimic condition as

jitteriness, benign neonatal sleep myoclonus, motor automatisms,

hyperekplexia, and Sandifer syndrome..

Trial population

The study population includes neonates aged 0 to 30 days admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children's Hospital who are diagnosed with neonatal convulsions. Both full-term and preterm infants of either sex will be included. Neonates with conditions mimicking seizures (e.g., jitteriness, benign neonatal sleep myoclonus, motor automatisms, hyperekplexia, Sandifer syndrome) will be excluded. The target population is expected to be representative of neonates admitted to the NICU with convulsions during the study period from March 2024 to August 2025.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Management of Neonatal Convulsions

    Other intervention

    This intervention involves the clinical management of neonatal convulsions in newborns aged 0-30 days admitted to the NICU. Management includes prompt identification of seizure activity through clinical evaluation and EEG confirmation, followed by appropriate treatment using anticonvulsant medications such as phenobarbital. Supportive care includes monitoring of vital signs, glucose, and electrolytes, and performing necessary investigations like abdominal ultrasound, echocardiography, and brain imaging (MRI/CT) to identify underlying causes. The intervention aims to control seizures, minimize neurological complications, and improve short-term and long-term outcomes in affected neonates.

Treatment groups

139 Participants
are divided into 1 treatment group
Group A: Neonatal Convulsions1 intervention

Trial outcomes

Primary outcomes

1

Rate of neonatal convulsions in newborns admitted to the NICU

The proportion of neonates diagnosed with convulsions confirmed clinically and by EEG during hospitalization in the neonatal intensive care unit.

Time frame
During NICU stay (up to 30 days of age)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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